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Randomized Placebo Controlled Trial of Budesonide-MMX™ 6 mg and 9 mg in Patients With Ulcerative Colitis


Trial Overview

StatusConditionSponsor/Collaborator(s)First ReceivedLast ChangedVerification Date
Completed Ulcerative Colitis Santarus Industry
collaborator(s): Cosmo Technologies Ltd
May 14, 2008 February 9, 2012 February 2012

Study TypeStudy DesignPhaseEnrollmentStart DateEnd Date
Interventional Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment Phase 3 514 June 2008 -

Locations

FacilityAddressContactPhoneEmailStatus
Centre for Digestive Diseases Sydney New South Wales 2046 Australia - - - -
Royal Adelaide Hospital Adelaide 5000 Australia - - - -
Box Hill Hospital, Department of Gastroenterology Clive Ward Centre, Box Hill VIC 3128 Australia - - - -
Monash Medical Centre Melbourne 3168 Australia - - - -
The Alfred Hospital Melbourne 3004 Australia - - - -
Imelda Hospital Bonheiden Belgium - - - -
East Viru Central Hospital Kohtla-Jarve 30322 Estonia - - - -
West Tallinn Central Hospital Tallinn 10617 Estonia - - - -
East Tallinn Central Hospital Tallinn 10138 Estonia - - - -
Tartu University Hospital Tartu 51014 Estonia - - - -
Hôpital Beaujon Clichy Cedex France - - - -
Hospital Saint-Louis Paris France - - - -
CRO - IRCCS - Struttura Operativa Complessa di Gastroenterologia Oncologica Aviano 33081 Italy - - - -
Dipartimento di Medicina Interna e Specialità Mediche (DIMI) Genova 16132 Italy - - - -
Divisione di Gastroenterologia - Istituto Clinico Humanitas IRCCS in Gastroenterologia Milan 20098 Italy - - - -
Daugavpils Regional Hospital Daugavpils 5417 Latvia - - - -
Clinical University Hospital Gailezers Riga 1038 Latvia - - - -
Paula Stradina Clinical University Hospital Riga 1002 Latvia - - - -
Digestive Disease Centre Gastro Riga 1006 Latvia - - - -
Kaunas Medical University Hospital Kaunas 50009 Lithuania - - - -
Siauliai District Hospital Siauliai 76231 Lithuania - - - -
M.Marcinkeviciaus Hospital Vilnius 03215 Lithuania - - - -
Vilnius University Hospital Santariskiu Klinikos Vilnius 08661 Lithuania - - - -
Centrum Leczenia Chorób Cywilizacyjnych Warszawa Mazowieckie Poland - - - -
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Warszawa Mazowieckie 03-580 Poland - - - -
Gastromed S.C. Białystok Podlaskie 15-842 Poland - - - -
Gastromed S.C.Maciej Kralisz, Andrzej Penpicki, Jacek Romatowski, Gabinet, Gastrologiczny i Pracownia Endoskopowa Bialystok 15-842 Poland - - - -
NZOZ Centrum Leczenia Chorob Cywilizacyjnych, oddzial Gdynia, filia Fikakw Gdynia 81-572 Poland - - - -
NZOZ Centrum Leczenia Chorob Cywilizacyjnych Gdynia 81-572 Poland - - - -
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Gastroenterologii, Hepatologii i Chorob Zakaznych, Krakow 31-531 Poland - - - -
Szpital Uniwersytecki w Krakowie,Oddział Kliniczny Kliniki Gastroenterologii Hematologii i Chorób Zakaźnych Kraków 31-531 Poland - - - -
Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA Lodz 90-302 Poland - - - -
Endoskopia Sp. z o.o. Sopot 81-756 Poland - - - -
Endoskopia Sp.z o.o. Sopot 81-756 Poland - - - -
Indywidualna Specjalistyczna Praktyka Lekarska Wejherowo 84-200 Poland - - - -
NZOZ Polimedica Łódź 90-302 Poland - - - -
Spitalul Clinic Colentina Sectia Gastroenterologie Bucuresti 020125 Romania - - - -
Cabinet Medical Oradea Romania - - - -
Spitalul Judetean Sibiu Sibiu Romania - - - -
Centrul de Gastroenterologie Dr. Goldis Adrian Timisoara Romania - - - -
GU research educational medical centre of the administration of the affairs of the president of Russian Federation on the basis of State Healthcare Institution "State Clinical Hospital # 51" Moscow 121309 Russian Federation - - - -
Federal State Institution ?National Medical Surgical Center Moscow 105203 Russian Federation - - - -
GUZ of Moscow "City Clinical Hospital #24" Moscow 127006 Russian Federation - - - -
State Scientific Centre of Coloproctology of the Federal Agency for High-Technology Medical Care Moscow 123423 Russian Federation - - - -
Rostov State Medical University Rostov-on-Don 344022 Russian Federation - - - -
Saint-Petersburg GUZ City polyclinic #38 28 St Petersburg 193015 Russian Federation - - - -
St. Petersburg State Medical Academy n.a. I.I. Mechnikov St Petersburg Russian Federation - - - -
FGU North-West DIstrict Medical Center of Roszdrav St-Petersburg 199004 Russian Federation - - - -
Krestovsky Ireland Medical Institute St-Petersburg 197110 Russian Federation - - - -
ZAO Clinic Dvizhenie Volgograd 400107 Russian Federation - - - -
Yaroslavl Region Clinical Hospital Yaroslavl Russian Federation - - - -
FNsP Bratislava, Nemocnica Ruzinov V. Interna klinika, Gastroenterohepatologicke oddelenie Ruzinovska Bratislava 826 06 Slovakia - - - -
FNsP Bratislava, Nemocnica Stare Mesto 1st Internal Clinic Mickiewiczova Bratislava 813 69 Slovakia - - - -
Gastroenterologické a Hepatologické centrum Nitra 94901 Slovakia - - - -
NsP Nove Mesto nad Vahom n.o. Nové Mesto nad Váhom Slovakia - - - -
Sahlgrenska Univerity Hospital Göteborg 416 85 Sweden - - - -
Lund University Hospital Lund 221 85 Sweden - - - -
Div. of Gastroenterology and Hepatology Stockholm 118 83 Sweden - - - -
IBD-Unit, Sophiahemmet Stockholm 11486 Sweden - - - -
Dept. of Gastroenerology and Hepatology Stockholm 171 76 Sweden - - - -
Chair of Gastroenterology and therapy of Dnipropetrovsk State Medical Academy based on Institute of gastroenterology Dnepropetrovsk 49074 Ukraine - - - -
City Clinical Emergency Hospital named after O.I.Meschaninov, Kharkov 61018 Ukraine - - - -
Lviv National Medical University after name Danylo Halytsky based on Communal Clinical City hospital No 5, Department of Propedeutic of Internal Disease Lviv 79013 Ukraine - - - -
Odessa city Polyclinic #20, Therapeutic Dept. 6 Odessa 65114 Ukraine - - - -
Uzhgorod State Medical University, chair of therapy and family medicine, district clinical hospitalof station "Uzhgorod" Uzhorod Ukraine - - - -
Uzhgorod National University, Hospital surgery chair on the base of Uzhgorod Regional Clinical Hospital Uzhorod Ukraine - - - -
John Radcliffe Hospital Headington Oxford OX3 9DU United Kingdom - - - -
University Hospital of Coventry and Warwickshire Coventry CV2 2DX United Kingdom - - - -
Gastrointestinal Unit Edinburgh EH4 2XU United Kingdom - - - -
St Marks Hospital Harrow HA1 3UJ United Kingdom - - - -

Intervention

TypeInterventionDescription
Procedure Blood sampling, endoscopy Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
Drug Budesonide MMX® 6 mg 6 mg/day, 6 mg tablets
Drug Budesonide MMX® 9 mg 9 mg/day, 9 mg tablets
Drug Entocort EC® 3 mg 9 mg/day, 3 mg tablets
Drug Placebo Placebo

Outcome

TypeMeasureTime FrameSafety Issue
Primary To evaluate the clinical efficacy and safety of budesonide-MMX™ (CB-01-02) 6 mg and 9 mg oral tablets in patients with active mild or moderate ulcerative colitis, when administered for 8 weeks, and compared to placebo 8 weeks Yes
Secondary Efficacy & safety of oral budesonide-MMX 6 mg and 9 mg compared to 3 times daily Asacol®. To evaluate the improvement in rectal bleeding,endoscopic, histological, bio humoral parameters. 8 weeks Yes

Official Title

Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC

Description

Each patient will receive one of the following regimens in the morning after breakfast:

1. One budesonide MMX® 6 mg tablet plus three placebo Entocort EC® overencapsulated
capsules, or

2. One budesonide MMX® 9 mg tablet plus three placebo Entocort EC® overencapsulated
capsules, or

3. Three placebo Entocort EC® overencapsulated capsules plus one placebo budesonide MMX®
tablet, or

4. Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX®
tablet, daily for eight weeks.

Hence, each patient is to take four tablets/capsules per day of active or placebo study
medication as per the randomization schedule. Placebo tablets of Budesonide MMX® and
placebo overencapsulated capsules of Entocort EC® will be used to maintain the study blind
using a double-dummy technique.

During the study, five visits to the clinical center are scheduled: one at Screening and
three in the double-blind treatment period (Day 1, Day 14, Day 28 and Day 56). A safety
follow-up visit will take place about 2 weeks after the final study visit. If a patient is
withdrawn from the study before Day 56, they will be asked to attend the study center as
soon as possible thereafter so that the Final visit assessments can be conducted.

Eligibility

GenderMinimum AgeMaximum AgeHealthy Volunteers
Both - 75 Years No

Inclusion Criteria:

- Patients fulfilling the following criteria at the screening visit are eligible for
participation in the study:

- Male and female patients, 18-75 years old, suffering from ulcerative colitis for
at least 6 months.

- Diagnosis of ulcerative colitis in active phase, of mild or moderate entity with
Ulcerative Colitis Disease Activity Index (UCDAI) ≥ 4 and ≤ 10 according to
Sutherland.

- All females of child-bearing potential must have a negative serum pregnancy test
immediately prior to enrollment. In addition, all females of child-bearing
potential must agree to be completely abstinent or be using an accepted form of
contraception throughout the entire study period. Accepted forms of
contraception are defined as those with a failure rate <1% when properly applied
and include: combination oral pill, some intra-uterine devices, and a sterilised
partner in a stable relationship. Female subjects must also not be actively
breast-feeding through the entire study period.

- Ability to comprehend the full nature and purpose of the study, including
possible risks and side effects.

- Ability to co-operate with the investigator and to comply with the requirements
of the entire study.

- Must be able to understand and voluntarily sign written informed consent prior
to inclusion in the study.

Exclusion Criteria:

- Patients who meet any of the following criteria at screening visit are to be excluded
from study participation:

- Patients with limited distal proctitis (from anal verge up to 15 cm above the
pectineal line).

- Patients with severe ulcerative colitis (UCDAI >10).

- Patients with infectious colitis.

- Evidence or history of toxic megacolon.

- Severe anaemia, leucopaenia or granulocytopaenia.

- Use of oral or rectal steroids in the last 4 weeks.

- Use of immuno-suppressive agents in the last 8 weeks before the study.

- Use of anti tumour necrosis factor alpha (anti-TNFα) agents in the last 3
months.

- Concomitant use of any rectal preparation.

- Concomitant use of antibiotics.

- Concurrent use of CYP3A4 inducers or CYP3A4 inhibitors. See Section 4.2, Table 5
for complete list.

- Patients with verified, presumed or expected pregnancy or ongoing lactation.

- Patients with liver cirrhosis, or evident hepatic or renal disease or
insufficiency, and/or severe impairment of the bio-humoural parameters (i.e. 2 x
upper limit of normal for ALT, AST, GGT or creatinine).

- Patient with severe diseases in other organs and systems.

- Patients with local or systemic complications or other pathological states
requiring a therapy with corticosteroids and/or immuno-suppressive agents.

- Patients diagnosed with type 1 diabetes.

- Patients diagnosed with, or with a family history of, glaucoma.

- All patients with known hepatitis B, hepatitis C or with human immunodeficiency
virus (HIV), according to the local privacy policy.

- Participation in experimental therapeutic studies in the last 3 months. (Note:
patients who participated in observational only studies are not excluded).

- Any other medical condition that in the principal investigator's opinion would
make the administration of the study drug or study procedures hazardous to the
subject or obscure the interpretation of adverse events (AEs).